The board said a comparison between the falsified tablets and genuine Postinor-2 revealed several differences.The Pharmacy and Poisons Board has cautioned Kenyans over the circulation of a falsified batch of the emergency contraceptive Postinor-2.
The Board said levonorgestrel 0.75mg tablets, batch number T34197R, had been detected in the market while being misleadingly marketed as a genuine emergency contraceptive.
“This batch of falsified Postinor-2 may contain incorrect amounts of the active ingredient, no active ingredient at all, harmful contaminants, or undeclared substances, and therefore may not provide the intended therapeutic effect.”
The Board said the falsified product was identified through its post-marketing surveillance activities, which monitor health products circulating in the Kenyan market.
It said a comparison between the falsified tablets and genuine Postinor-2 revealed several differences, including the batch printing method, printing and typographical errors on the Patient Information Leaflet, and the carton sealing method.
The Board also noted that the orange colour used on the brand name and other areas of the pack was significantly more intense than that on the genuine product.
It further said the font of the logo revealed after scratching the authentication panel differed from that of the genuine pack.
The observations, the Board said, strongly indicated that batch T34197R was falsified and had not been manufactured or released as a genuine product.
"This falsified product was found in circulation in the Kenyan market," the Board said.
The drug safety agency said it had arrested two people found in possession of the falsified product as multi-agency investigations continued to establish its source, point of entry into the country and extent of distribution within the supply chain.
The Board said it would continue to take firm regulatory and legal action against all persons found to be involved in the manufacture, importation, distribution or supply of falsified health products and technologies.
Meanwhile, the regulator has issued a public advisory urging vigilance to enhance public safety as the investigations, which it said were at an advanced stage, progress.
Healthcare professionals have been advised to verify the authenticity of stocks before dispensing and quarantine any suspected falsified products.
Procurement agencies, hospitals, distributors, pharmacists, pharmaceutical technologists and members of the public have also been urged to immediately report any encounter with the falsified batch of pills.
Stakeholders within the supply chain have further been advised to procure health products and technologies exclusively from licensed manufacturers, importers, distributors and retailers.
"Procuring from unlicensed sources endangers patients and constitutes a violation of the Pharmacy and Poisons Act, Cap 244 of the Laws of Kenya," the Board said.
